Title: Design Quality Senior Supervisor
Location: Maple Grove, MN, US, 55311
Department: Quality Assurance, Reliability
Job Description:
Additional Location(s): N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.
About the role:
We have an exciting opportunity for Design Quality Senior Supervisor supporting single use devices within the BSC's Interventional Cardiology division. This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential and sustaining engineering experience. In a hybrid work mode, the Design Quality Senior Supervisor will support a team of engineers and technicians to apply the directives of design controls to projects such as design changes, regulatory and standards compliance, corrective and preventive actions, improvements for manufacturability, and cost-reduction efforts.
Your responsibilities include:
Supervise direct reports (engineers and/or technicians) in design quality including assignment and operational oversight of small to medium projects within the sustaining organization.
In-depth understanding and application of Design Control and Risk Management concepts. Provide quality and compliance input to project teams & mentoring to direct reports for project decisions and deliverables.
Support the execution and documentation of Design Validation & Verification and Usability activities.
Lead and participate in Design Quality initiatives. Influence implementation of quality system changes/requirements to commercial devices.
Creation and review of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode, and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA). Understand and support linkage of product performance data and Risk Management.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies).
Provide quality guidance to assure country specific compliance.
Champion compliance to company policies, work instructions, and SOPs.
Provide quality and compliance input for post market product sustaining activities, such as design changes, customer complaint investigations, NCEP's, CAPA's PIRs, Field Signals Evaluations and Field Actions.
Support internal and external regulatory audits as required.
Support collection and analysis of key quality trending information and data for Management Review and Complaint Reviews. May present product performance at SER/CRB.
Distinguish work responsibilities between design quality and cross functional roles (technical writers, engineers, DQA, R&D, PM, Packaging/Labelling, etc.)
What we're looking for in you:
Required Qualifications:
Bachelor's degree in engineering or science discipline, or equivalent.
Minimum of 5 years experience in design assurance, quality, or related medical device or regulated industry experience
ISO 13485, ISO 14971, CFRs, and Quality System Regulations understanding & demonstrated use
Strong communication skills (verbal & written) and presentation skills
Problem solver, capable of facilitating the problem-solving process & driving issues to closure
Excellent organizational and planning skills; drives for results
1+ years of direct or indirect supervisory experience
Travel approximately
